Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

Hormones released from the brain may mediate the behavioral response to stress.

It had two arms (groups): oxytocin (experimental) and placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 33 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 0 inclusion and 16 exclusion criteria; among the exclusions: subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments; subjects must consent to random assignment; subjects must consent to outpatient admission to the ctrc.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2011-07 with completion listed for 2012-10.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Salivary Cortisol Levels (time frame: 0 minutes post 15 minute stress task).

It also tracked 2 secondary outcomes, for example Likert Scale Rating of Subjective Stress and Likert Scale Rating of Subjective Craving.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 33 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.